FDA Inspection 807190 — Zi Xiu Tang Success, LLC
The FDA completed an inspection of Zi Xiu Tang Success, LLC on October 24, 2012 in Kutztown, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 24, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Kutztown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15623 | 21 CFR 111.180(b)(2) | Records - receiving; components, packaging, labels, products |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16045 | 21 CFR 111.503 | Written procedures returned dietary supplement; reprocessing |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |